GPS (Giving Parents Support): Parent Navigation After NICU Discharge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Parental Self-Efficacy
研究概览
简要总结
BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be classified as children with special health care needs (CSHCN) who will require health and related services of a type or amount beyond that required by children generally. NICU parents report increased anxiety and stress during their stay and transition home from the NICU. Short-term peer-to -peer programs during hospitalization decrease stress, anxiety and depression for mothers, however, no studies have evaluated the effects of long term post-discharge peer support. Children's National (CN) provides medical home services to CSHCN through its Parent Navigator Program (PNP). Parent Navigators (PNs) are CSHCN parents who provide peer emotional support, access to community resources, and assistance with navigating complicated health systems. NICU graduates and their caregivers may benefit from support provided by PNs after discharge. No data regarding the impact of PNs on patient and family outcomes of the NICU graduate are available.
OBJECTIVE: To assess the impact of a PNP on a parent's self-efficacy, stress, anxiety, depression; infant health care utilization, and immunization status.
METHODS: 300 NICU graduates will be randomized to receive either PN for 12 months (intervention group) or usual care (comparison group). Baseline data at 1 week, 1, 3, 6, and 12 months after discharge will be collected from caregivers in both groups including scales for self-efficacy, stress, anxiety, and depression, infant healthcare utilization and immunization status. Outcomes will be compared at 12 months.
PATIENT OUTCOMES (PROJECTED) The study outcomes are parental self-efficacy, stress, anxiety, and depression; infant health care utilization and immunization status.
ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in the NICU can reduce anxiety and depression in caregivers. It is unclear whether peer support after discharge, when a family is faced with the total care of their child without structured supports, can significantly impact parents' ability to care for their child. The investigators anticipate that this simple intervention will increase self-efficacy in caregivers, reduce stress, anxiety, and depression, in turn resulting in improved health outcomes for their child.
详细描述
Specific Aims:
Infants who are discharged from the neonatal intensive care unit (NICU) almost invariably have high levels of health care needs in the first year after discharge, requiring multiple sub specialist visits, medications, and/or medical technology needs. Parents of NICU infants are often overwhelmed by the needs of their infants after they are discharged home and frequently have few supports to help them cope. This study will investigate the impact of peer to peer support through a Parent Navigation program for NICU graduates and their parents. The study aims will be achieved through a randomized controlled trial of Parent Navigation using a care resource notebook as the control intervention.
The specific aims of this study are to:
- Determine if Parent Navigation increases overall parental self-efficacy and decreases stress among parents caring for a child with a special health care need (CSHCN) when measured at repeated time points during the 12 months after NICU discharge.
Hypothesis 1a: Parent Navigation will increase parental self-efficacy, when compared with the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •parents of neonates receiving care in the Children's National NICU
排除标准
- •infant is not being discharged with a custodial parent (e.g., in custody of Child Protection Services)
- •neither parent can complete an interview in English,
- •the parent who will be providing most of the care is younger than 18 years of age,
- •those with insufficient knowledge of English to participate in the telephone interviews
- •the parent/caregiver has plans to leave the District of Columbia (DC) metropolitan area permanently within the following year.
研究组 & 干预措施
Care Notebook
Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight.
干预措施: Care Notebook (Behavioral)
Care Notebook + Parent Navigator
Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight.
干预措施: Parent Navigator (Behavioral)
Care Notebook + Parent Navigator
Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight.
干预措施: Care Notebook (Behavioral)
结局指标
主要结局
Parental Self-Efficacy
时间窗: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
Parental self-efficacy was measured using the Perceived Maternal Parenting Self-Efficacy Questionnaire (PMPS-E). Mean scores were determined and compared between groups. PMPS-E scores can range from 20-80, and higher scores indicate higher levels of parental self-efficacy.
次要结局
- Parental Depression(baseline; 1 month, 3 months, 6 months, 12 months after discharge)
- Infant Developmental Status(One year)
- General Stress(baseline, 1 week, 1 mo, 3 mo, 6 mo, 12 months after discharge)
- Parental Stress in the Neonatal Intensive Care Unit(Baseline)
- Infant Immunization Status(One year)
- Parental Stress(baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge)
- ED Visits(One year)
- Hospitalizations(One year)
- Parental Anxiety(baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge)
研究者
Karen Fratantoni
MD
Children's National Research Institute